MEETING. of Transfusion Service Information

Transcription

1 Second Integration Annual or Pathology Disintegration All Staff MEETING of Transfusion Service Information Suzanne H. Butch, MLS(ASCP) CM, SBB CM, DLM CM University of Michigan Hospitals and Health Centers Ann Arbor, Michigan 1

2 Objectives Define the current state Identify deficiencies in software Suggest changes that will improve transfusion documentation

3 Disclaimer I am not describing any specific systems I am speaking in general terms Software is constantly changing I speak from my personal experiences and from those of my colleagues at other institutions Only the vendor can describe the current and potential functionality and capabilities of their system(s)

4 Transfusion Services Are costly Don t make money Lack significant consultation fees Highly regulated

5 System Wish List Tracking from patient specimen collection through the system and unit back to patient Patient correctly identified at any time they interaction with the healthcare system Patient identification system used Barcoded specimen label created at the bedside Label placed on tube at the bedside Phlebotomist ID traceable

6 Wish List -2 Barcoded label used throughout processing Receipt in lab Automated testing Manual testing Software designed to prevent data entry errors Transfusion record form/id tag contains barcoded information Unit labeling verified at dispense

7 Wish List -3 Patient/Unit/Compatibility verified at the bedside Transfusion Service software talks to software doing the verification process Double verification Patient ID Unit/product Transfusion record form contains barcoded information

8 Wish List -4 Vital signs and transfusion documentation in the electronic patient medical record Transfusion information sent back to the transfusion service information system Transfusion service information system records the date/time and final disposition of the unit Data can be collected and analyzed for utilization review, biovigilance, regulatory reporting

9 Customers Patients Physicians Nurses Clerks Transfusion service staff Billing Quality management Regulatory agencies

10 LAB Anesthesiology ADT Pharmacy Biovigilance Perfusion Imaged Documents Histocompatbility External Blood Refrigerators OR Nursing OB BBTX Blood Center Clinical Order Entry Emergency Patient Scheduling Lab Instruments Data Repository Equipment Maintenance ICU Nursing Organ Transplant Risk Management Temperature Monitoring Billing Security Clinical Documentation Dietary? Devices Irradiators, Freezers, Centrifuges Point of Care

11 Needs Genetic testing Sickle/thal Hard to crossmatch Imaging Type fonts a person over 40 can easily read Fatter fonts Good use of white space Popups to avoid scrolling

12 Silos

13 Connected Silos

14 Looks Connected

15 Multiple Systems One Dashboard Not all here OB Intraoperative Nursing Notes

16 Attempts at Connections Instrument interfaces Older standards based on ASTM or European coding systems HL-7 Expanding to include donor center data LOINC Codabar, ISBT 128

17 TX2 PRBC ASAP Multiple clicks after identifying the correct patient Order specimen collection Order for products dumps in the blood bank does not write an order in the LIS Does not order a crossmatch Send blood request from nurse

18 Question How do I find out how much blood was transfused to my patient? Answer: Count the paper records in the medical chart Wait for the paper records to be scanned Look in the Emergency Department computer system Look in the nursing notes for the inpatient visit Look in the records of five different databases Call the Blood Bank Presumed transfused

19 Attempt to Give Information

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21 Question From Pathology Resident A call has come in from the donor center concerning an apheresis platelet from a double collection A patient at another facility has what could be a reaction from a the transfusion of a bacterially contaminated unit Was the unit transfused? To whom? When?

22 Question From the Medical Records: Hard to tell We know when it left the blood bank and to whom is was assigned When was the unit transfused? When the transfusion was entered into the patient record Maybe Two people signed the paper transfusion record form but no date/time Dated and timed on-line Anesthesia record says 1 unit of platelets but no specific unit number

23 What Really Happened It s actually not transfused It was found the following morning without its accompanying transfusion record form improperly stored in the ICU blood refrigerator Massive transfusion: documentation takes place after the fact on forms removed from the units in a batch

24 Question The head of the transplant department wants to know how many units were transfused and the age of the units at the time of transfusion. Can you send this information to merge with their data base?

25 Answer: No Date of collection is not in the database for units received from the blood supplier Future: File sent from blood supplier to hospital with all needed information Receiving system has a place to put the data Only barcode to read is the unit number not all of the barcodes on the unit to receive the unit or Scan box with RFID reader

26 Question Asked by Chief Medical Officer of the Institution Can the new Pharmacy medications administration system be used for transfusion documentation? Answer: No The NDC number on the drug is unlike the barcode on the blood components Different software needs for data capture The dreaded 510k process specifically avoided blood component application

27 Question Can the person who collected the specimen be reliably determined? Answer: Not really The system records a name of a person printing a label This may or may not be the person who actually collected the unit Where the label prints is critical The further away from the patient the label prints the more likely the label is inaccurate

28 Impediments Lack of contemporaneous record keeping Actual transfusion date and time is not in the database Barcode technology Codabar still used & ISBT 128 not readable by all software Collection date is not in the database Information is dynamic and not static Imaged documents are not searchable

29 Regulations Premarket Notification (PMN) - also called 510(k) Medical Device Submissions Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance.

30 Premarket Notification If Intend to introduce a device into commercial distribution for the first time or Reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected Change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use

31 SEC [21 USC 360c] Under section FDA must classify devices into one of three regulatory classes Class I- general controls are sufficient Class II- special controls Class III- premarket approval Classification panel convened to make determinations

32 Class III If there is insufficient information the device is a life-sustaining or life-supporting device or is for a use which is of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury

33 Equivalent Device New" devices (not in commercial distribution prior to May 28, 1976) Equivalent to a device already placed into one of the three classification categories CDRH Substantially Equivalent 510(k)s are available ~ the 5th of each month

34 Equivalent to?

35 What class is it? Does it need a 510k? Is it integrated with the blood transfusion laboratory software? Does it perform a control function? Does it report back to the blood transfusion laboratory software?

36 Does it Have a 510 (k)? Source: CAP Today July 2011 Issue Vendor Cerner Bridge Cerner Millennium Was 510K obtained? Endur ID - Iatric Systems Korchek Technologies Lattice McKesson Horizon SCC Soft Computer SoftID SCC Soft Computer SoftID-Tx Siemens Healthcare Patient Identification Check Sunquest Collection Manager /Transfusion Manager Yes Yes Unnecessary Yes Unnecessary Unnecessary Unnecessary Yes Yes Yes

37 Institute of Medicine The 510k The underlying assumption is that if a new device is equivalent to a previous similar device, it will be at least as safe and effective as that device Recommendation to eliminate the 510(k) clearance process for medical devices Establish and implement post-market surveillance systems

38 510k Process Drawbacks Separation of blood bank software Lack of vendors Reluctance/slowdown of process to make modifications Multiple interfaces to other systems In summary: the 510k process fails to provide the intended protection and inhibits advancement

39 Lack of Standardization Transfusion service operations are quite variable Software may not accept data in the manner it is provided Limited error prevention

40 Lack of Standardization How do I know this is the same patient? Interfaces between Transfusion Service software and devices may be limited or not available Humans make decisions on what to include in the interface Work-arounds screen scrapes to transfer data

41 Lack of Process Controls Identification of the person performing each significant step in the process Inventory and Lot number control lacking Temperatures & humidity Equipment used Reagents used

42 21 CFR (c)(13) Container Labeling Machine readable Unique facility identifier Lot number relating to the donor Product Code ABO and Rh of the donor Must be unique to the blood or blood component Approved symbology (Codabar, ISBT-128)

43 What s on the Unit? Blood Bag Label Codabar ISBT-128 Patient Identification Label or Tag Recipient s two identifiers Donation identification number or pool number Interpretation of compatibility tests, if performed

44 Codabar Red Cross Unit Numbers NNAANNNNN N = Number A = Alpha Eye Readable Prefix + Alphas converted from numbers + 5 digits Donation site ID barcode is in the bottom right In the unit number barcode Start Code +Numbers + Stop Code A D Where the number 24 is converted to FH

45 Unit Number A D FH96075 Supplier Prefix Copyright ICCBBA, Inc

46 21 CFR (c) Laboratory Controls Adequate identification and handling of all test samples so that they are accurately related to the specific unit of product being tested, or to its donor, or to the specific recipient, where applicable.

47 How Is A Patient Identified? Name Birthdate Medical Record Number Encounter/visit/billing number Case number OR software Bed number

48 Medical Record Number Lacking a Social Security Number or national patient identifying number facilities must assign their own identifying number. Must do a history check for antibodies and serious reactions before transfusion A name searches set up the potential for errors

49 Newest Technology?

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51 What s on the Wristband? Eye readable Patient Full Name Patient birthday Patient visit or billing number Patient permanent medical record number Barcode readable Patient medical record number? Patient visit or billing number? Both (2-D) All patient information (2-D)

52 Barcodes Have data identifiers (location identifiers) Wristband Specimen tube Paper record label Transfusion record form Blood Unit Employee ID Others

53 The Joint Commission (TJC) Folks outside the laboratory care about TJC National Patient Safety Goals Label at the bedside NPSG Label containers used for blood and other specimens in the presence of the patient. (See also NPSG , EP 1)

54 TJC - Use Two Identifiers NPSG Use at least two patient identifiers when administering medications, blood, or blood components; when collecting blood samples and other specimens for clinical testing; and when providing treatments or procedures. The patient's room number or physical location is not used as an identifier. (See also MM , EPs 8 and 11; NPSG , EP 1)

55 TJC National Patient Safety Goal NPSG Before initiating a blood or blood component transfusion: - Match the blood or blood component to the order. - Match the patient to the blood or blood component. - Use a two-person verification process or a oneperson verification process accompanied by automated identification technology, such as bar coding. (See also NPSG , EPs 1 and 2)

56 CLSI Tube Label Specimen/accession number Human Readable Options Ordering physician (authorized prescriber) Test order name or number Collection priority: routine, stat Source of specimen (eg, nasal swab) Site of specimen (eg, left side of chest, leg wound) Space for instructions, or information (eg, keep at 4 C) Temperature class Collection order of tubes Container size (eg, 5-mL) Container type (eg, lavender-top tube) Collection class: laboratory section (eg, hematology, immunology, where and to whom it is to be sent)

57 TRM Misidentification Risk The facility has a plan to implement a system to reduce the risk of mistransfusion for nonemergent red cell transfusions. Note: The laboratory is expected to participate in the development of a plan to reduce these risks through implementation of a risk-reduction system. Among options that might be considered are: (1) Documenting the ABO group of the intended recipient on a second sample collected at a separate phlebotomy (including documentation in the institution's historical record);

58 TRM Misidentification Risk (2) Utilizing a mechanical barrier system or an electronic Identification verification system that ensures that the patient from whom the pretransfusion specimen was collected is the same patient who is about to be transfused. Other approaches capable of reducing the risk of mistransfusion may be used. The laboratory should participate in monitoring the effectiveness of the system that it implements. The laboratory should also consider improvements in procedures and/or educational efforts as part of its program to reduce the risk of mistransfusion.

59 At the Patient Side Universal Barcode (RFID) reader Label Printer Computer/hand held With applications that can Parse data into the correct fields Provide useful warnings Can be read by a person over 40

60 AABB Transfusionist must verify matching the blood unit and intended recipient Two patient identifiers ABO group & Rh of patient Donation identification number, ABO group and Rh of donor Interpretation of crossmatch tests Special transfusion requirements Data may not be in the clinical database Expiration date/time of the unit

61 Electronic Crossmatch 1992 Use still less than hoped Regulatory ineptness Poorly written software

62 HIPPA Called other hospitals to obtain information about previous transfusions and problems Patient release of information form Call back through hospital switchboard National registry of antibodies

63 Problem Summary Data needed to assess blood transfusion effectiveness is scattered in multiple unlinked computer systems The 510k process for premarket approval of Blood Bank and Transfusion Service software inhibits development and data integration Current Transfusion Service software fails to assist the user in many functions

64 Federal Level Recommendations Ditch the 510k system Foster software development Transfusion Services Challenge vendors to Allow easy data transfer Improve their product to prevent errors Continue to emphasize safety over efficiency as a value

65 Vendors Design to prevent errors Making using the system easier than working around it Design to capture cgmp steps Accept information from devices Adopt current data transfer standards Design blood bank instruments to work on an automation line Quit using the 510k process as an excuse for developing useable integrated software